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Language and Emotional Function in Patients With Temporal Lobe Epilepsy

Primary Purpose

Epilepsy, Temporal Lobe

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Epilepsy focused on measuring Seizures, Language, Memory, Brain, Imaging, Epilepsy, Temporal Lobe Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Patient Group: Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan. Native English speaker. Age 18 years or older. Signed informed consent. Volunteer Group: Native English speaker. Age 18 years or older. Signed informed consent. EXCLUSION CRITERIA: Patient Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc; History of mental retardation; Pregnancy; Claustrophobia; Inability to comply with the protocol. Volunteer Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.); History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation. Pregnancy. Claustrophobia. Inability to comply with the protocol.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2004
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00081432
Brief Title
Language and Emotional Function in Patients With Temporal Lobe Epilepsy
Official Title
Functional MRI (fMRI) and Diffusion Tensor Imaging (DTI) in Temporal Lobe Epilepsy
Study Type
Observational

2. Study Status

Record Verification Date
April 27, 2010
Overall Recruitment Status
Completed
Study Start Date
April 9, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 27, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
This study uses functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) to examine how the brain processes tasks involving language and emotion in normal volunteers and in patients with epilepsy. MRI is a diagnostic and research tool that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a magnetic field. During the test, the subject lies on a table that can slide in and out of the cylinder. DTI involves taking pictures of the brain while the subject is at rest in order to learn about the structure of the brain. Information gained from this study will help scientists evaluate the organization of language and emotional functions in the brain. Normal volunteers and patients with temporal lobe epilepsy 18 years of age and older who are native English speakers and who will undergo surgery for uncontrolled seizures may be eligible for this study. Candidates are initially screened by telephone, then with physical and neurologic examinations and cognitive testing. The study has two parts, conducted 6 to 12 months apart. Each part consists of the same sets of tests described below, using fMRI and DTI. In patients with epilepsy, Part 1 is scheduled before surgery and Part 2 after surgery. fMRI: Subjects are asked to perform two types of tasks while they undergo fMRI. In one task, they are shown pictures of animals and tools and are asked to name them. In a second task, they are shown pictures that range in content from sexually explicit material, to human injury and surgical slides, to pleasant images of children and wildlife and are asked to decide whether they find the pictures pleasant, neutral, or unpleasant. DTI: Subjects relax and remain still in the MRI scanner for about 45 minutes. Neuropsychological testing: Subjects may be asked to complete questionnaires, take pen-and-paper or computerized tests, and perform motor tasks. Participants may be asked to repeat the MRI studies, but not the neuropsychological tests, up to four times to investigate different brain functions or to confirm findings.
Detailed Description
OBJECTIVES: Epilepsy surgery is emerging as a potent therapeutic intervention for a large group of patients with uncontrolled temporal lobe epilepsy, particularly when performed early in the course of the illness. Seizure freedom is an important goal of seizure surgery, but post-operative neuropsychological functioning is another equally important outcome measure. Both endpoints require careful pre-operative evaluation of the individual patient and better understanding of the functional neuroanatomy of the temporal lobe. In this study fMRI and DTI will be performed in patients with temporal lobe epilepsy and normal volunteers in an attempt to investigate the role of the anterior temporal cortex in semantic processing, evaluate the role of the amygdala in affective processing, correlate the extent of white matter pathway resection with cognitive outcome after temporal lobectomy. STUDY POPULATION: We plan to study 30 patients with temporal lobe epilepsy (right-sided, left-sided seizure foci) pre and post temporal lobectomy as well as 30 normal volunteers. DESIGN: The study will be done in two parts both consisting of identical tasks. For the patient group part 1 will be performed prior to temporal lobectomy and part 2, 6-12 months after temporal lobectomy. For the normal volunteer group parts 1 and 2 will be performed at time interval of 6-12 months. During part 1 all study subjects will undergo neuropsychological evaluation. FMRI will be performed with two tasks: animal and tool naming (to evaluate semantic processing) and rating of emotionally pleasant or unpleasant pictures (to evaluate affective processing). All subjects will also undergo diffusion tensor imaging (DTI) for the visualization of white matter pathways. During part 2 of the study all of the above tests will be repeated. FMRI data will be analyzed within the framework of the general linear model in a program such as AFNI 2.5. Statistical comparisons between activation patterns in scans acquired during part 1 and part 2 within either group (intragroup comparison) will be done by voxel wise paired t-test. In a second analysis all 4 groups will be compared in a mixed model. The DTI data will be correlated with the neuropsychological outcome to asses the contribution of white matter abnormalities pre-operatively or severance of white matter pathways post-operative on neuropsychological functioning. OUTCOME PARAMETERS: Outcome parameters are changes in the fMRI activation pattern post temporal lobectomy and disruption of anisotropy on the diffusion tensor images.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Temporal Lobe
Keywords
Seizures, Language, Memory, Brain, Imaging, Epilepsy, Temporal Lobe Epilepsy

7. Study Design

Enrollment
20 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Patient Group: Temporal lobe epilepsy (right-sided, left-sided foci) with or without lesion on a structural MRI scan. Native English speaker. Age 18 years or older. Signed informed consent. Volunteer Group: Native English speaker. Age 18 years or older. Signed informed consent. EXCLUSION CRITERIA: Patient Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc; History of mental retardation; Pregnancy; Claustrophobia; Inability to comply with the protocol. Volunteer Group: Medical or technical contraindications to MRI procedures (e.g. no braces, pacemakers, cochlear devices, surgical clips, etc.); History of neurologic or psychiatric disease or a learning or attention disorder or mental retardation. Pregnancy. Claustrophobia. Inability to comply with the protocol.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1635805
Citation
Barnes PD. Imaging of the central nervous system in pediatrics and adolescence. Pediatr Clin North Am. 1992 Aug;39(4):743-76. doi: 10.1016/s0031-3955(16)38374-2.
Results Reference
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PubMed Identifier
11025519
Citation
Basser PJ, Pajevic S, Pierpaoli C, Duda J, Aldroubi A. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. doi: 10.1002/1522-2594(200010)44:43.0.co;2-o.
Results Reference
background
PubMed Identifier
9621916
Citation
Basser PJ, Pierpaoli C. A simplified method to measure the diffusion tensor from seven MR images. Magn Reson Med. 1998 Jun;39(6):928-34. doi: 10.1002/mrm.1910390610.
Results Reference
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Language and Emotional Function in Patients With Temporal Lobe Epilepsy

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